Do you develop software for medical devices or does your medical product contain product-related software? Manufacturers of medical devices or of components for the medical device industry have to take into account a variety of regulatory requirements during the development of their product. But not only the development process is affected, it also implies the compliance to processes like usability, risk analysis or problem and change management. However, even the actual implementation as well as the creation of the necessary documents and records can prove to be problematic.
Fischer Consulting GmbH offers support for the design, establishment and implementation of development processes. Furthermore, we will support you during the implementation of development projects and the creation of the technical file. Due to our many years of experience in software development we have focussed on the area of software-intensive systems.
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